510(k) · Cleared
ClearedFine TTO™
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bodycad Laboratories, Inc. · PBF Orthopaedic Surgical Planning And Instrument Guides
Cleared on Oct 21, 2025 as substantially equivalent to K241356 (Bodycad Laboratories, Inc., 2024) after a 251-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Oct 21, 2025
- Review
- 251 days
- Class
- Class II
- Product code
- PBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K000682 (2000). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK000682 Synthes Large Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000
- 2 generations backK141796 Depuy Synthes Tomofix Osteotomy SystemSynthes (USA) Products, LLC · 2014
- 1 generation backK241356 Fine Osteotomy™Bodycad Laboratories, Inc. · 2024
- This deviceK250394 Fine TTO™Bodycad Laboratories, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000682 | Synthes Large Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | — |
| −2 | K141796 | Depuy Synthes Tomofix Osteotomy System | Synthes (USA) Products, LLC | 2014 | — |
| −1 | K241356 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | 2024 | — |
| 0 (this device) | K250394 | Fine TTO™ | Bodycad Laboratories, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PBF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PBF device
- #1 K241811 MedCAD® AccuStride™ Systemscore 17.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K241356 | Fine Osteotomy™Summary page 5….3030 Product Code(s) PBF, HWC I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K241356 Fine Osteotomy PBF Device Description Summary 21 CFR 807.92(a)(4) The Fine TTO™ system is designed specifically for tibial tuber… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 10.0 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 1 other device also cites its predicate K241356.
How does its category compare?
All PBF devicesPBF Orthopaedic Surgical Planning And Instrument Guides: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PBF
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PBF
227in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PBF
No recall names PBF since 2007.
Adverse event reports per year · PBF
62in 2025
MAUDE reports naming product code PBF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 2 | — | 0 | 12 |
| 2022 | 3 | 435 | 0 | 53 |
| 2023 | 5 | 314 | 0 | 45 |
| 2024 | 3 | 62 | 0 | 34 |
| 2025 | 8 | 227 | 0 | 62 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Fine TTO™ is a patient-specific system intended for tibial tuberosity osteotomies (TTO) in skeletally mature patients.
The device is intended to assist in pre-operative planning and in guiding surgical instruments during the procedure, and should be used only when the anatomical landmarks required for planning can be clearly identified on the patient's radiographic images.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K250394 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250394: Fine TTO™.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250394
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026